Promoting mental health and well-being in schools: examining mindfulness, relaxation and strategies for safety and well-being in English primary and secondary schools—study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)

Daniel Hayes, Anna Moore, Emily Stapley, Neil Humphrey, Rosie Mansfield, Joao Santos, Emma Ashworth, Praveetha Patalay, Eva Maria Bonin, Sara Evans-Lacko, Bettina Moltrecht, Kirsty Nisbet, Emma Thornton, Aurelie Lange, Paul Stallard, Abigail Thompson, Jan Rasmus Boehnke, Jessica Deighton

Research output: Contribution to journalArticlepeer-review

Abstract

There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based universal prevention programmes are thought to be one way of helping tackle such difficulties. This paper describes an update to a four-arm cluster randomised controlled trial (http://www.isrctn.com/ISRCTN16386254), investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. Due to the COVID-19 pandemic, the trial was put on hold and subsequently prolonged. Data collection will now run until 2024. The key changes to the trial outlined here include clarification of the inclusion and exclusion criteria, an amended timeline reflecting changes to the recruitment period of the trial due to the COVID-19 pandemic and clarification of the data that will be included in the statistical analysis, since the second wave of the trial was disrupted due to COVID-19. Trial registration ISRCTN Registry ISRCTN16386254. Registered on 30 August 2018.

Original languageEnglish
Article number220
JournalTrials
Volume24
Issue number1
DOIs
Publication statusPublished - 23 Mar 2023

Bibliographical note

Funding Information:
This research was commissioned and funded by the Department for Education. The department selected the interventions to be trialled and also chairs an advisory group the researchers report to regarding the progress and quality of the research. However, the department had no role in the design of this study and will not have any role in the analyses, interpretation of the data or decision to submit results. The views expressed are those of the authors and not necessarily those of the Department for Education. JD was (in part) supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart’s Health NHS Trust. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Availability of data and materials
An anonymised quantitative dataset generated and/or analysed during the
current study will be available in 2024 once the study has fnished. A decision
regarding storage location is yet to be fnalised. Please contact the principal
investigator or trials manager for further information.

Keywords

  • Adolescent
  • Children
  • Cluster randomised controlled trial
  • Mental health
  • School-based
  • Well-being
  • Young person

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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